Recruitment Strategy Substudy for the National Children's Study (NICHD)

ICR 201105-0925-001

OMB: 0925-0593

Federal Form Document

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Justification for No Material/Nonsubstantive Change
2011-05-11
Supplementary Document
2011-05-11
Supplementary Document
2011-05-11
Supplementary Document
2011-04-08
Supplementary Document
2011-04-08
IC Document Collections
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193580 Modified
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ICR Details
0925-0593 201105-0925-001
Historical Active 201104-0925-002
HHS/NIH
Recruitment Strategy Substudy for the National Children's Study (NICHD)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 06/01/2011
Retrieve Notice of Action (NOA) 05/13/2011
Note to file - change in number of responses without change in burden was to correct an administrative error.
  Inventory as of this Action Requested Previously Approved
07/31/2013 07/31/2013 07/31/2013
455,206 0 440,665
159,966 0 159,966
0 0 0

The Initial Vanguard Study protocol was designed to enroll approximately 1,750 pregnant women through seven study locations after 12 months of data collection. Two of the locations began recruitment in January 2009 and the remaining 5 in April 2009. As of May 2010, however, approximately 900 pregnant women have been enrolled, leading to questions about the assumptions underlying the Initial Vanguard Study recruitment model. The seven Initial Vanguard sites use a household enumeration and screening strategy to identify eligible women for recruitment into the study. Although household enumeration is often considered a gold standard for maximizing coverage, in that all dwelling units are identified and enumerated, for the NCS Initial Vanguard Study this method has not yielded the target number of births in the time frame projected from initial models. Consequently, additional methodological research is needed to evaluate the feasibility, acceptability, and cost of alternate recruitment strategies for enrollment of pregnant women into the NCS. This research will be conducted through the NCS Recruitment Substudy. The Recruitment Substudy will assess three alternate recruitment strategies - (1) a provider-based recruitment strategy; (2) an enhanced version of a household enumeration strategy; and (3) a two-tier recruitment strategy involving high-intensity and low-intensity data collection efforts.

PL: Pub.L. 106 - 310 1004 Name of Law: Childrens Health Act of 2000
  
None

Not associated with rulemaking

Yes

30
IC Title Form No. Form Name
Address Lookup Tool (PB)
Pregnancy Screener (PB, EH, TT-HI) 2.1, 2.2, 2.3 Survey ,   Survey ,   Survey
Healthcare Provider Questionnaire (PB) 3.1 Survey
Household Enumeration Instrument (EH) 4.1 Survey
Low-Intensity Invitation to High-Intensity Script (TT-HI) 5.1 Survey
Pregnancy Screener (TT-LI, TT-HI) 6.1 Survey
Pregnancy Health Care Log (PB, EH, TT-HI) 17.1 Log
Father Informed Consent Form (PB, EH, TT-HI) 18.1 Consent
Father Interview (PB, EH, TT-HI) 19.1 Survey
Birth Visit Interview (PB, EH, TT-HI) 20.1 Survey
Low-Intensity Questionnaire (Birth focus) (TT-LI) 21.1 Survey
Infant Feeding Log (PB, EH, TT-HI) 22.1 Log
Low-Intensity Questionnaire (Child-focus) (TT-LI) 23.1 Survey
3-Month Phone Call (PB, EH, TT-HI) 24.1 Survey
6-Month Visit Interview (PB, EH, TT-HI) 25.1, 25.2 Survey ,   Survey
9-Month Phone Call (PB, EH, TT-HI) 26.1 Survey
12-Month Visit Interview (PB, EH, TT-HI) 27.2, 27.1 Survey ,   Survey
18-Month Maternal Phone Call (PB, EH, TT-HI) 28.1, 28.2 Survey ,   Survey
24-Month Maternal Phone Call (PB, EH, TT-HI) 29.1, 29.2 Survey ,   Survey
Formative - Developmental
Low-Intensity Consent Script (TT-LI) 7.1 Consent
Non-pregnant Women's Informed Consent (PB, EH, TT-HI) 8.1 Consent
Pre-Pregnancy Interview (PB, EH, TT-HI) 9.1, 9.2 Survey ,   Survey
Biological and Environmental Sample Collection (PB, EH, TT-HI) 10.1 Survey
Pregnancy Probability Group Follow Up Script (PB, EH, TT-HI, TT-LI) 11.1, 11.2 Survey ,   Survey
Low-Intensity Questionnaire (Non- and Pregnant) (TT-LI) 12.1 Survey
Validation Script (PB, EH, TT-HI, TT-LI) 13.1 Survey
Pregnant Women's Informed Consent Form (PB, EH, TT-HI) 14.1 Consent
Pregnancy Visit 1 Interview (PB, EH, TT-HI) 15.1, 15.2 Survey ,   Survey
Pregnancy Visit 2 Interview (PB, EH, TT-HI) 16.1, 16.2 Survey ,   Survey

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 455,206 440,665 0 14,541 0 0
Annual Time Burden (Hours) 159,966 159,966 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$27,000,000
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Mikia Currie 3014350941

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
05/13/2011


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